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PET-MR Imaging of Coronary Atherothrombosis

Combined Positron Emission Tomography and Magnetic Resonance Imaging of Coronary Atherothrombosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03618303
Enrollment
9
Registered
2018-08-07
Start date
2018-07-16
Completion date
2020-03-24
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases, Ischemic

Brief summary

Heart attacks remain a common cause of death throughout the world. The most common initiating event is the formation of a blood clot within the coronary arteries occluding blood supply to the heart. However, we know that thrombus often occurs within the coronary arteries without causing any symptoms, and may be found in patients with stable angina. We wish to investigate whether blood clots within the coronary arteries can be detected in patients who have had a heart attack and in patients with stable angina using combined positron emission tomography and magnetic resonance (PET-MR) imaging. If possible, this may provide a safe and noninvasive means of identifying patients at higher risk of heart attacks. The study will be conducted in Edinburgh Heart Centre and a total of 40 participants will be recruited from the cardiology wards, outpatient clinics and day case unit. Participants will be asked to undergo a single PET-MRI scan in addition to invasive angiography as part of standard care (non-research procedure). During the invasive angiogram procedure, an additional imaging test may be performed called Optical Coherence Tomography to provide images from within the heart blood vessels.

Interventions

DIAGNOSTIC_TESTPET-MRI scan

Patients will undergo combined Positron Emission Tomography and Magnetic Resonance Imaging prior to a planned invasive angiogram (performed as standard of care). During the angiogram procedure, an additional imaging test (optical coherence tomography) will be performed.

Sponsors

University of Edinburgh
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Previously diagnosed coronary artery disease undergoing elective invasive angiography OR * Admitted with acute coronary syndrome diagnosed by two of the following criteria 1) Elevation of cardiac biomarkers (High sensitivity cardiac troponin I greater than 34 ng/l in men and 16ng/l in women) 2) Symptoms of myocardial ischaemia 3) ECG changes indicative of acute ischaemia

Exclusion criteria

* Contraindication or inability to undergo MRI scanning * Renal failure (estimated glomerular filtration rate less than 30mL/min * Undergoing Primary PCI * Ongoing myocardial ischaemia or dynamic ECG changes * Inability to provide informed consent * Known allergy to gadolinium based contrast * Women who are pregnant, breastfeeding or of child-bearing potential

Design outcomes

Primary

MeasureTime frameDescription
Plaque-to-myocardial ratio of culprit plaques on T1-weighted imagingBaselineThe identification of high risk plaques on T1-weighted MRI to determine whether coronary atherothrombosis can accurately be detected using non-invasive PET-MR imaging.

Secondary

MeasureTime frameDescription
The correlation between high risk plaques on PET-MR and culprit plaques on invasive angiography in patients with coronary artery disease.BaselineThe relationship between positive plaques identified on PET-MR by both T1-weighted MRI and 18F-NaF PET and culprit plaques on invasive angiography
The correlation between coronary plaque thrombosis (MRI), high-risk plaque (PET) and the presence of myocardial infarction on MRI (late enhancement).BaselineThe relationship between high risk plaque features on MRI and PET with evidence of myocardial infarction on MRI.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026